# Neuroone Medical Technologies Corp.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 4 (2021–2025): 4 510(k) clearances
- Product codes: GZL (2), GXI (1), GXD (1)
- 510(k) review time since 2016: median 115 days, against 183 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 6 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cosman Medical, Inc.: 2 (https://510kreport.com/company/cosman-medical)
- Dixi Medical: 1 (https://510kreport.com/company/dixi-medical)
- Leslie W. Organ: 1 (https://510kreport.com/company/leslie-w-organ)

## Firms that cite its devices most
- Beijing Sinovation Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-sinovation-medical-technology)

## Its most-cited devices
- K222404: Evo® sEEG System (2022), cited by 1
- K211367: Evo sEEG System (2021), cited by 1
- K231675: OneRF Ablation System (2023), cited by 1

## Recent decisions
- K251243: OneRF Trigeminal Nerve Radiofrequency Probes (Aug 15, 2025)
- K231675: OneRF Ablation System (Dec 6, 2023)
- K222404: Evo® sEEG System (Oct 20, 2022)
- K211367: Evo sEEG System (Sep 1, 2021)

Source page: https://510kreport.com/company/neuroone-medical-technologies